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EMA restricts use of anti-PD-1 drugs for bladder cancer

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  • Role of Bone Metastases in Patients Receiving Immunotherapy for Pre-Treated Urothelial Carcinoma: The Multicentre, Retrospective Meet-URO-1 Bone Study

    2022, Clinical Genitourinary Cancer
    Citation Excerpt :

    Immune-checkpoint inhibitors (ICIs) have an established role in mUC, particularly for the treatment of platinum-refractory disease and, more recently, in the maintenance setting after platinum-based chemotherapy. ICIs are also approved for patients who are ineligible for cisplatin in the first-line setting.8-18 Although clinical experience suggests a detrimental effect of BoM on outcomes in both first- and subsequent-lines treatments with ICIs,19 none of the published studies investigated the implication of bone involvement in patients exposed to immunotherapy.

  • Post-translational modifications in bladder cancer: Expanding the tumor target repertoire

    2020, Urologic Oncology: Seminars and Original Investigations
  • Neuroendocrine Carcinoma of the Urinary Bladder: A Large, Retrospective Study From the French Genito-Urinary Tumor Group

    2020, Clinical Genitourinary Cancer
    Citation Excerpt :

    Immunotherapy has shown promising results in the management of both SCLC and UC. Atezolizumab21,22 and pembrolizumab23 can be used as first- or second-line therapy in the management of metastatic UC.24 In addition, because of the high mutational burden, SCLC has been shown to benefit from immunotherapy with atezolizumab.25,26

  • Clinical outcome after progressing to frontline and second-line Anti–PD-1/PD-L1 in advanced urothelial cancer[Formula presented]

    2020, European Urology
    Citation Excerpt :

    In 2017, the European Medicines Agency (EMA) and the Food and Drug Agency (FDA) granted accelerated approval to atezolizumab and pembrolizumab for first-line metastatic cisplatin-ineligible UC based on single-arm phase II clinical trial data [7,8]. The label has recently been restricted by the EMA and FDA based on early preliminary data from ongoing first-line phase III clinical trials [9,10]. These unpublished data suggest reduced survival in mUC patients treated with frontline ICIs with low PD-L1 status (≤5% in tumor-infiltrating immune cells or <10% combined positive score, assessed by Ventana SP142 and Dako 22C3, respectively) when compared with chemotherapy.

  • Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab and pembrolizumab

    2019, European Journal of Cancer
    Citation Excerpt :

    Because these assays are expensive and not reimbursed by health insurances in several EU countries, this could lead to a widespread withholding of a potentially effective therapy. Furthermore, prior studies demonstrated that PD-L1 assays are not standardised, leading to different staining results potentially affecting appropriate treatment selection [12–16]. Interobserver effects might further affect appropriate therapy selection [17,18].

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